- Professor, inflammatory bowel diseases are serious diseases. What are they?
- What is the treatment of patients with Crohn's disease or ulcerative colitis?
- Biological treatment is included in the drug program …
- For what reasons was the drug refund period limited to one year?
- So it's the only reason? There is no medical reason to stop treatment?
- And what about the drug program for patients with Crohn's disease?
- What are the consequences of stopping medication after a year or two?
- Is there any hope that the programs will be changed also in the case of intestinal diseases?
Treatment of IBD patients is currently subject to administrative constraints. Prof. dr hab.n.med. Jarosław Reguła from the Department of Gastroenterology, Hepatology and Clinical Oncology of the Medical Center of Postgraduate Education in Warsaw.
Professor, inflammatory bowel diseases are serious diseases. What are they?
The group of inflammatory bowel diseases (IBD) consists of two main diseases: ulcerative colitis, a symptom of which is diarrhea with blood caused by inflammation, and Crohn's disease, which, apart from diarrhea, has many different systemic manifestations (it can be in the large intestine, small intestine and other parts of the digestive tract are involved)
Both diseases are practically incurable. Complications of Crohn's disease and its sequelae may vary. It may result in the production of internal, perianal fistulas, narrowing in the intestines that prevent passage and require surgical treatment, abscesses may form in the abdominal cavity.
Even cutting out the diseased section is not effective because the changes appear in other places. It is even recommended to abstain from surgical procedures, because removing the next fragments may eventually lead to their lack, and a person is not able to live without the proper length of the intestines.
What is the treatment of patients with Crohn's disease or ulcerative colitis?
It must start with the fact that not all patients are treated the same way. A small percentage of people with inflammatory bowel disease require biological treatment, while for those who have mild or moderate disease, medications are generally referred to as classic.
They are anti-inflammatory, systemic or local, depending on the severity of symptoms and the location of the lesions. Steroid preparations that are administered to induce remission and immunosuppressive treatments are also administered briefly.
These methods are considered effective and sufficient in most cases. In contrast, biological treatment is required for approximately 5-10 percentpatients with the most severe forms of inflammatory bowel disease.
Biological treatment is included in the drug program …
Yes. In Poland, there is now a large availability of preparations that are available under therapeutic programs financed by the Ministry of He alth. This means that you cannot simply buy a given preparation at a pharmacy, but you can obtain it at a treatment center.
For patients requiring biological treatment, two therapeutic programs have been created - for each of the above-mentioned diseases.
Patients with ulcerative colitis are treated with three modern preparations: one is in the form of intravenous infusions, the other - subcutaneous injections, and the third - tablets. Each of these drugs can be administered for a maximum of one year - this is how long the refund takes. P
otem we have to stop the treatment and wait for the exacerbation that comes sooner or later. It happens that patients have an exacerbation soon after stopping their medication, but sometimes remission takes several months.
For what reasons was the drug refund period limited to one year?
These are expensive preparations and, of course, you try to limit your expenses.
So it's the only reason? There is no medical reason to stop treatment?
There are such situations, but rarely. Sometimes a patient has side effects or the drug is found to be ineffective - about 30 percent of patients this is the case. If the drug does not give any improvement, there is no point in continuing it. But the main concern for most patients is administrative constraints.
And what about the drug program for patients with Crohn's disease?
Likewise. As for the second program, we have 4 modern biological drugs available, two of which we can use for a maximum of a year, and two for a maximum of two years. Over the past few years, the Ministry of He alth has done a lot of good for patients with Crohn's disease.
New innovative drugs were introduced, they became just as available as in the world. So the number of drugs and their selection is fantastic. Currently, the problem of the need to stop treatment for administrative reasons after a year or two of successful treatment remains.
Unfortunately, in the case of Crohn's disease, there is another problem worth mentioning. These are quite restrictive rules for including a patient in the program. You need to have the severity of your symptoms, which is measured on a special scale. These criteria are much stricter than in the West.
That's why it's easier to get into the program there, because the symptoms don'tmust be as serious as in patients from Poland.
What are the consequences of stopping medication after a year or two?
If the patient had indications for biological treatment and he feels well after taking biological drugs, it is in the period of so-called remission. Then, usually after a year or two, there comes a time when the drug has to be discontinued because it is no longer financed. It is not possible for the patient to pay for it himself or for the hospital to pay extra for the drug, because the prices of the preparations are very high.
This situation has many disadvantages. First, the patient will have a relapse sooner or later. And then there is a risk of complications, i.e. the appearance of all the symptoms I mentioned at the beginning.
Moreover, some programs state that you have to wait, for example, two or three months from the end of the previous treatment, in order to be able to reintroduce the same drug, because an exacerbation of symptoms is a necessary condition for the reimbursed preparation to be used again .
Even if we return to using the drug, after a year or two we have to stop the therapy again and the situation repeats itself. Here is the second problem. Stopping treatment and starting the medicine may cause your body to develop antibodies to this medicine. Due to these antibodies produced by the body, the remedy simply stops working.
Since IBD is a life-long disease and the number of biological drugs is limited, it is a pity to lose one of three or one of four drugs just because you have to stop the therapy for administrative reasons. A general rule of thumb is that while a drug is effective, it should be used without stopping it as long as it works.
Is there any hope that the programs will be changed also in the case of intestinal diseases?
We are very happy that we have all these drugs available in the west, it is a success of the last two or three years. But now, the next step has to be to do something that allows the treatment to continue indefinitely.
In the case of some autoimmune diseases it has already happened, a decision was made to modify the therapeutic programs so as not to interrupt the treatment once undertaken.
I sincerely hope that this will also be the case in IBD, because it is logical and justified from the point of view of biology and benefits for patients. If the patient feels well after the drug, he or she can return to normal life, to work. And these are often young people, 20-year-olds, 30-year-olds entering their adult life, they want to have families, children.
It's very important to keep a remission likefor the longest time and avoid complications that may have fatal consequences. We, the doctors, write about it to the ministry on every occasion, we try to raise it and remind it. We only need to wait.